The Journal of the American Medical Association published the pivotal trial results for Medtronic's Hybrid Closed Loop system.
The multicenter study involved 124 people with type 1 diabetes.
Here are six observations:
1. The published data revealed the safety of the Hybrid Closed Loop, which is intended to automate the delivery of basal insulin to maximize the time glucose levels are in a healthy range.
2. The publication also outlined the trial's findings for the patients on the therapy:
• Less glycemic variability
• More time in the target range
• Less exposure to hypoglycemia and hyperglycemia
• Decreased A1c levels compared to baseline data
3. Ultimately, the study found patients receiving the Hybrid Closed Loop system therapy saw improved glucose control with no safety issues.
4. Richard M. Bergenstal, MD, of the International Diabetes Center in Minneapolis, served as principal investigator of the study.
5. In June, Medtronic submitted a pre-market application to the FDA for the Hybrid Closed Loop system.
6. The Hybrid Closed Loop system is not yet approved for commercial sale.